SOS: Health Canada is making significant regulatory changes to natural health products (NHPs). These unnecessary changes will treat NHPs like pharmaceutical drugs.
This over-regulation will negatively impact how NHP brands can do business forcing a downstream effect on retailers and consumers.
Major regulatory changes are happening to our industry all at once:
- New user fees for regulatory activities (aka Cost Recovery)
- New labelling requirements (Plain Language Labelling)
New User Fees for Regulatory Activities (aka Cost Recovery)
Background
- Cost Recovery is the process of collecting user fees for services, including regulatory activities such as product evaluation, site licenses and annual renewal fees.
- Fees are payable based on the service provided, regardless of a company’s size, although Health Canada does recognize that these fees can be a significant strain to small business and puts certain measures in place provide support.
- Health Canada recently announced the fee program for NHPs. Public consultation is open until July 26, 2023.
Why This is Important
- The foundation of our regulatory system is stretched to the brink with massive backlogs in product applications – data used to establish this program is dramatically flawed.
- The timing of implementing this program at the same time as new labelling requirements will financially decimate many companies in our industry, making it extremely challenging for them to stay viable.
- These regulatory changes are unfair, unrealistic, and so costly they will force many small to medium-sized businesses to shut down
- Canadian operations. If it goes through as planned those businesses that stay open will struggle to stay afloat, prices will increase, product availability will suffer, and many brands will leave the Canadian market altogether. We will have less access to NHPs and pay much more for what’s available.
- Industry needs to be involved in the consultation of this program in a meaningful way – brands, retailers and consumers are encouraged to participate by filling in the online form here.
New Labelling Requirements (Plain Language Labelling, PLL)
Background
- Health Canada stated that new labelling requirements are intended to present label information in a legible and comprehensive manner – this is to reduce confusion, medical errors, product interactions and to allow consumers to locate information about safe use.
- For NHPs this introduces a standardized Product Facts Table (PFT) and various other new labelling requirements such as the labelling of allergens and contact information. All current NHP labelling requirements continue to apply, specifically what is required on the principal display panel (PDP) of a label.
- Government did not take into account industry feedback on these changes, conduct user testing or consult labelling sciences to ensure the changes would result in a clearer, more consumer-friendly label. What they did create was a guidance document that is very technical and inflexible, making it hard for brands to comply.
- The law is final as of June 21, 2022, and the regulations have been updated, however they are not enforced until June 21, 2025.
Why This is Important
- Real estate for mandatory information will be limited – many brands will need to increase the size of their labels (and packaging) creating dramatic increases in the use of plastic, fuel, glue, wood and water. This has serious implications on our environmental footprint and will force brands to increase costs to accommodate for higher packaging costs.
- Ingredient monographs, which will help inform the development of the Product Facts Tables, have still not been consulted on – this is putting considerable strain on meeting the June 2025 timeline.
- When over-the-counter (OTC) products went through a similar change in 2017-2021, 1 out of 6 products left the Canadian market as a result of discontinuations or due to costs/regulatory complexities.
How else will these changes impact Canadian NHPs?
Increased Prices & Lack of Availability
Many brands you use will see dramatic price increases or stop existing in Canada altogether. 1/5 brands said they are seriously considering leaving Canada.
Decreased Product Choice
Complicated and unnecessary changes will force brands to evaluate their product line and drop products that are too expensive or unprofitable resulting in less variety. In a recent survey over 70% of brands said they would have to pull product from market if changes go through.
No Love for Local
Small, local businesses that cannot afford to navigate increasingly complex regulations and lengthy approval processes will be priced out of business. 83% of companies said it will be challenging to absorb the costs of these changes.
Nothing New
Exciting new products and international brands will likely not come to Canada because the regulatory burden will be too severe.
Environmental Burden
New regulations are increasing the amount of packaging (for the same amount of product), reduce recyclability, adversely impacting the environment.
For more information visit saveoursupplements.ca or get in touch at [email protected]
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